The Pancreatic Cancer Action Network recently announced Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer. The organization also announced the 12 initial Precision Promise Clinical Trial Consortium sites selected to participate in this groundbreaking initiative.

Bringing together the field’s key stakeholders, including clinicians, researchers, and diagnostic and drug developers, Precision Promise will put the patient at the center of every decision and will advance the Pancreatic Cancer Action Network’s goal to double survival by 2020. The Pancreatic Cancer Action Network has committed a minimum initial investment of $35 million over the first 4 years, not including drug costs, and expects to enroll thousands of patients.

Julie Fleshman, JD, MBA

“Precision Promise will dramatically accelerate the clinical trial process to bring promising therapies to patients faster,” said Julie Fleshman, JD, MBA, President and CEO of the Pancreatic Cancer Action Network. “Precision Promise is an unprecedented opportunity for patients and is vital to move the field forward. Instead of looking for the right patient for a clinical trial, we are designing the right clinical trial for each patient.”

Trial Design

To change the pancreatic cancer treatment paradigm, Precision Promise will investigate multiple treatment options, called substudies, under one clinical trial design that utilizes an individualized treatment approach based on the molecular profile of a patient and his or her tumor.

The substudies are designed to be nimble and dynamic, so a patient can shift to another option quickly without wasting time between clinical trials. The system will constantly evolve the treatment options by integrating current research and the most up-to-date science and knowledge available.

Substudies can be added for newly discovered biomarkers and treatment approaches, so the field can learn which patients will most benefit from these new developments and get new, effective treatments to patients sooner.

Victoria Manax Rutson, MD

“Precision Promise is an opportunity to change the landscape of how we conduct pancreatic clinical trials,” said Victoria Manax Rutson, MD, Chief Medical Officer at the Pancreatic Cancer Action Network. “We will be able to offer options to patients based on the molecular profile of their tumor, rather than trying to fit them into a clinical trial that may not suit the needs of their disease.”

Starting in the spring of 2017, participating patients will enroll in Precision Promise at a local Clinical Trial Consortium site. Patients will undergo advanced molecular profiling to determine their tumor’s unique molecular features, which will inform which Precision Promise substudy will best match their individual needs. Once on treatment, patients will be monitored closely, and follow-up analyses will be conducted to provide important clues to help researchers quickly understand the effectiveness of each treatment in real time.

Currently, important genetic data and clinical trial results are fragmented across various institutions and drug developers, and some important results may never be shared publicly for researchers to learn from these findings.

Lynn Matrisian, PhD, MBA

“Through Precision Promise, all data from the initial 12 Clinical Trial Consortium sites will be analyzed together, so scientific findings are gathered and disseminated to the research community in a timely manner,” said Lynn Matrisian, PhD, MBA, Chief Research Officer at the Pancreatic Cancer Action Network. “This model ensures that data and information are shared as quickly as possible for patient benefit.”

Precision Promise will partner with the health-tech company Tempus to utilize its cutting-edge genomic sequencing and analysis methods. Tempus collects and analyzes large amounts of genomic data using statistical analysis, machine learning, and proprietary algorithms to help physicians make real-time, data-driven decisions for their patients. Also, Cancer Research and Biostatistics will serve as the Precision Promise Contract Research Organization, to provide statistical analyses and data-management support as well as clinical monitoring for the trials.

In addition to the scientific learnings from collective data, oppurtunities for targeted precision medicine grant funding will also be made available by the Pancreatic Cancer Action Network, which will help inform and influence the direction of future therapeutic options through Precision Promise.

Andrew Biankin, MBBS, PhD

Diane Simeone, MD

The Precision Promise infrastructure is uniquely collaborative and cooperative, led by an executive committee co-chaired by Andrew Biankin, MBBS, PhD, of the University of Glasgow, and Diane Simeone, MD, of the University of Michigan, and features working groups of leading experts and diagnostic and drug developers, all of whom are providing expertise and guidance. Supporting the effort are initial members of the Industry Working Group, Promise Patrons Halozyme Therapeutics, Merrimack Pharmaceuticals, Tempus, and Trovagene, Inc.

“We are extremely grateful to all of the experts and companies that have provided input and support to date,” Dr. Fleshman said. “Our goal is to include the entire pancreatic cancer scientific and medical community in this initiative, and we look forward to joining forces with many more researchers, clinicians, and drug companies as this effort gets off the ground.” ■